1. Field of the Invention
The present invention relates to an aqueous wound and mucous membrane disinfectant on the basis of octenidine dihydrochloride, which contains further ingredients from the group ethanol, propan-1-ol, propan-2-ol, undecylene amidopropyl trimonium methosulfate, sodium hydroxymethylglycinate, and 3-(4-chlorophenoxy)-1,2 propanediol. The disinfectant according to the present invention has a pH value of from 5 to 7 and is free of phenoxyethanol, phenoxypropanol, phenoxyisopropanol and organic acids.
2. Discussion of the Background Information
A wound and mucous membrane disinfectant should primarily meet certain microbiological requirements, which are described, for example, in F.-A. Pitten, H.-P. Werner, A. Kramer, “A standardized test to assess the impact of different organic challenges on the antimicrobial activity to antiseptics,” Journal of Hospital Infection (2003) 55, 108-115. However, increasing importance is also being attached to the wound, skin or mucous membrane tolerance of a corresponding disinfectant.
Most of the active ingredients hitherto customary exhibit substantial deficits in terms of their tolerance. Iodine and PVP-iodine frequently trigger allergies with hypersensitivity, moreover, the skin is strongly colored and iodine, particularly from alcoholic solutions, penetrates through the skin and even more markedly through the mucous membrane, which can lead to hyperthyroidosis and even iodism in sensitive persons. Although these side effects are slighter with PVP-iodine, they are likewise manifest.
In addition to iodine and PVP-iodine and the alcohols, chlorhexidine and salts thereof are the most important active ingredients in antiseptics worldwide, although these compounds are viewed critically from a toxicological standpoint. Chlorhexidine is positive in the Ames Test and in the DNA Repair Test. Both results indicate a mutagenic potential. The breakdown products 4-chloraniline and 4-chlorophenyl isocyanate have a great affinity to the skin and concentrate there with frequent use. Triclosan, a chlorinated phenol, penetrates through the skin to a great extent and is a potential dioxin former.
Octenidine dihydrochloride is known as an active ingredient in mucous membrane and wound antiseptics and can be described by the limiting structure formulae below:

The raw material octenidine dihydrochloride has a good microbicidal effectiveness with relatively good tolerance. In DE 39 25 540 C1, an aqueous mucous membrane antiseptic is described, which contains phenoxyethanol and/or phenoxypropanol in addition to octenidine dihydrochloride to increase effectiveness. A preparation of this type is commercially available, e.g., under the name “Octenisept” and is often used in gynecology and andrology. However, recent tests have shown that the combination of octenidine dihydrochloride and phenoxyethanol has a high cytotoxicity, so that considerable reservations are justified regarding use on open wounds.
In WO-02/069874-A1 corresponding to DE 101 09 925-A1, wound and mucous membrane disinfectants are therefore described which, in addition to octenidine dihydrochloride, now contain ethanol and a physiologically tolerated organic acid instead of the above-referenced combination. The following are cited by way of example as organic acids: lactic acid, glycolic acid, malonic acid, succinic acid, malic acid, tartaric acid, or citric acid. The pH value of these solutions is 2.5 to 3.0. Acid preparations in this very low range can definitely be tolerated with infrequent use, but represent a noxa with longer-term application.
Basically all microbicidal active ingredients have a certain irritative potential, to which the mucous membranes react with particular sensitivity.
The object of the invention was therefore to develop a wound and mucous membrane disinfectant based on octenidine dihydrochloride, which on the one hand meets the microbicidal requirements—particularly with respect to the effectiveness regarding Candida albicans—but on the other hand has a more favorable pH value compared with the formulas of the prior art and thus a better wound, skin or mucous membrane tolerance.
Completely surprisingly and unforeseeable by one skilled in the art, these objects—particularly regarding the effectiveness with respect to Candida albicans—are met by an aqueous wound and mucous membrane disinfectant containing
a) octenidine dihydrochloride,
b) one or more active ingredients selected from the group ethanol, 1-propanol, 2-propanol, undecylene amidopropyl trimonium methosulfate, 3-(4-chlorophenoxy)-1,2-propanediol and/or sodium hydroxymethylglycinate,
c) glycerin and/or 1,2-diols having from 3 to 10 carbon atoms, and
d) optionally surfactants, emulsifiers, solubilisers, pH regulators, dyestuffs, perfumes and/or thickeners.
the agent being free of phenoxyethanol, phenoxypropanol, phenoxyisopropanol and organic acids.